Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines.

Guarding the Vaccine Cold Chain

FDA’s response to COVID-19 may impact the biologics industry long term.

The Impact of COVID-19 on Biologics Regulations

With vaccine development prioritized during the COVID-19 pandemic, innovations have to accelerated development processes.

Overcoming Vaccine Development Challenges

Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.

Vial or Prefilled Syringe?

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Articles

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis. 

CureVac Releases Interim Results from COVID-19 Vaccine Candidate Trial

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

Biden Administration Invests in Antiviral Medicines

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

PHE Analysis Demonstrates Efficacy of COVID Vaccines Against Delta Variant

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

Process Development Improvements Post-Pandemic

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

Novavax Reports on Two Vaccine Efficacy Studies

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

COVID-19 Update

Guarding the Vaccine Cold Chain

The Impact of COVID-19 on Biologics Regulations

Overcoming Vaccine Development Challenges

Vial or Prefilled Syringe?